Part 860 — Medical Device Classification Procedures
Current through Sep 8, 2026
Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374.
Source: 43 FR 32993, July 28, 1978, unless otherwise noted.
Editorial Note: Nomenclature changes to part 860 appear at 73 FR 35341, June 23, 2008, and at 86 FR 54846, Oct. 5, 2021.
Sections
- § 860.1 Scope.
- § 860.3 Definitions.
- § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.
- § 860.7 Determination of safety and effectiveness.
- § 860.10 Implants and life-supporting or life-sustaining devices.
- § 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
- § 860.84 Classification procedures for “preamendments devices.”
- § 860.90 Consultation with panels.
- § 860.120 General.
- § 860.123 Reclassification petition: Content and form.
- § 860.125 Consultation with panels.
- § 860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
- § 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
- § 860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
- § 860.134 Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
- § 860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
- § 860.200 Purpose and applicability.
- § 860.210 De Novo request format.
- § 860.220 De Novo request content.
- § 860.230 Accepting a De Novo request.
- § 860.240 Procedures for review of a De Novo request.
- § 860.250 Withdrawal of a De Novo request.
- § 860.260 Granting or declining a De Novo request.